The AFteR Registry - Follow-up Study to Monitor the Efficacy and Safety of the Occlutech AFR in Heart Failure Patients

Official title

A Multicentre, International, Follow-up Study to Monitor the Efficacy and Safety of the Occlutech Atrial Flow Regulator in Heart Failure Patients

Overview

This study aims to monitor the safety and efficacy of Occlutech AFR device in patients with Heart Failure.

Detailed description

This is a prospective, multicentre, international, follow-up registry to monitor the safety and the performance of the Occlutech AFR device in patients with Heart Failure, to identify unknown side effects and to assess the indications and contraindications for an AFR treatment. Efficacy and safety of implanted device(s) will be evaluated by vital signs, laboratory test, quality of life questionnaire, ECG, and echocardiography data over a follow-up period of 36 month after implantation.

Patients will be treated according to the instruction-for-use of the device and according to clinical routine. Procedures will be performed at sites having appropriate laboratory support and adequately trained imaging personnel. Procedures will be performed by physicians with experience in a wide range of interventional cardiology and structural heart disease.

Interventions

• Device Occlutech Atrial Flow Regulator
  The Occlutech Atrial Flow Regulator is an interatrial shunt device for transcatheter delivery.

Primary outcome measures

• Rate of subjects with at least one Major Adverse Cardiovascular and Neurologic Events (MACNE) in the 1 year following implantation. [Time frame: 1 year]

Secondary outcome measures (12)

• Rate of subjects with at least one SAE/ (S)ADE at 12 months, 24 months and 36 months after implantation. [Time frame: 3 years]
• Cardiovascular Events at 12 months, 24 months and 36 months after implantation. [Time frame: 3 years]
• Device performance at 12 months, 24 months and 36 months after implantation. [Time frame: 3 years]
• NYHA class status in comparison to Baseline. [Time frame: 3 years]
• Subject QoL assessment using the KCCQ in comparison to Baseline. [Time frame: 3 years]
• 6 Minute Walk Test distance [m] in comparison to Baseline. [Time frame: 3 years]
• Heart rhythm in comparison to Baseline [Time frame: 3 years]
• Left Ventricular (LV), Right Ventricular (RV) and Left Atrial (LA) structure and function including strain derived indices in comparison to Baseline. [Time frame: 3 years]
• Left Ventricular Ejection Fraction (LVEF) in comparison to Baseline. [Time frame: 3 years]
• Tricuspid Annular Plane Systolic Excursion (TAPSE) in comparison to Baseline. [Time frame: 3 years]
• Laboratory variables [Time frame: 3 years]
• Changes in heart failure related medication [Time frame: 3 years]

Eligibility criteria

Inclusion criteria

• Written, informed consent
• Age ≥18 years
• Presence of chronic symptomatic HF (NYHA class ≥ 2)
• Left Atrial Pressure (LAP) > Right Atrial Pressure (RAP); with a gradient equal or more than 5 mmHg\*
• LVEF ≥ 15%. If LVEF is >40% (HFpEF), BMI corrected\*\* NT-pro-BNP must be elevated ≥ 125 pg/mL. (BNP >35 pg/mL) or ≥ 365pg/ml (BNP > 105 pg/mL) for patients with atrial fibrillation (AF)
• Stable guideline directed treatment according to latest applicable ESC guidelines for respective HF phenotypes for at least 1 months prior to informed consent

Exclusion criteria

• Life expectancy < 1 year, or advanced heart failure defined as ACC/AHA Stage D heart failure, or listed for heart transplantation at time of baseline visit
• Evidence of right heart failure defined (by ECHO) as:

• Severe Right Ventricular Dysfunction (TAPSE < 14 mm)
• Severe Right Ventricular Dilatation (RV volume ≥ LV volume)
• Severe pulmonary hypertension (PASP > 60 mm Hg)
• Echocardiographic evidence of intra-cardia mass, thrombus or vegetation
• Uncontrolled hypertension, Systolic Blood Pressure of >160 mmHg or Diastolic Blood Pressure ≥ 100mmHg, despite medical therapy at the time of screening visit.
• Uncontrolled atrial fibrillation with resting heart rate >110bpm, despite medical therapy
• Documented history of specific cardiomyopathy (obstructive hypertrophic, restrictive, infiltrative) or pericardial disease
• Congenital heart defect that interferes with placement of the device, at the discretion of the Investigator.
• Previous interventional or surgical atrial septal defect (ASD) or patent foramen ovale (PFO) closure interfering with the placement of the device
• Current atrial septal defect, or anatomical anomaly (including > 10 mm atrial septal thickness or atrial septal aneurysm) on ECHO that precludes implantation of the device across the fossa ovalis (FO) of the interatrial septum
• Clinically significant valvular heart disease:

• regurgitation grade ≥3+ or
• severe stenosis of mitral or tricuspid valves, or
• significant stenosis of aortic valves
• Prior diagnosis of primary pulmonary hypertension
• Severe Chronic Obstructive Pulmonary Disease (COPD) requiring oral steroid therapy or oxygen administration
• History of stroke, transient ischemic attack (TIA), deep vein thrombosis (DVT), or pulmonary emboli within 6 months, or any prior stroke with persistent neurologic deficit, or any prior intracranial bleed, or known intracerebral aneurysm, AV malformation or other intracranial pathology increasing the risk of bleeding
• Myocardial Infarction (MI) and/or coronary heart disease with indication for a coronary intervention or Coronary Artery Bypass Grafting (CABG) or within 2 months prior to informed consent.
• ICD or right sided pacemaker placement within 2 months
• Clinically significant coagulation disorder, at discretion of investigator
• Patients with sepsis (local or generalized) or other acute infection(s) requiring systemic antibiotics in the two months prior enrollment
• Chronic kidney disease currently requiring dialysis
• Allergy to nickel and/or titanium and/or nickel/titanium-based materials, if not medically manageable
• Allergy to anti-platelet, anti-coagulant or anti-thrombotic therapy
• Participating in another investigational clinical trial that could interfere with this study, at the discretion of the investigator
• Other clinically significant co-morbidities that make the patient unsuitable for study participation, at the discretion of the investigator

Note: \* LA pressure is substituted by PCW at the right heart catheterization measure while patient is awaken

\*\*"Corrected" refers to a 4% reduction in the NT-proBNP cutoff for every increase of 1kg/m2 in body mass index (BMI) above a reference BMI of 20kg/m2)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Case-only

Study locations

Germany · 10 centers

• Knappschaftskrankenhaus Bottrop GmbH — Bottrop
• Clinic Coburg — Coburg
• University Clinic — Cologne
• Helios Clinic Erfurt — Erfurt
• Cardiologicum Hamburg — Hamburg
• WKK Heide — Heide
• University Clinic Jena — Jena
• Hospital Osnabrueck — Osnabrück
• … and 2 more centers

Turkey (Türkiye) · 9 centers

• Ankara Etlik Şehir Hastanesi — Ankara
• Güven Hospital — Ankara
• Hacettepe Üniversitesi Tip Fakültesi — Ankara
• Firat University Hospital — Elâzığ
• Binali Yildirim University Mengücek Gazi Training and Resear — Erzincan
• Bezmialem Uni. Hospital — Fatih
• İzmir City Hospital — Izmir
• Kocaeli Üniversitesi Araştirma Ve Uygulama Hastanesi — Kocaeli
• … and 1 more center

France · 5 centers

• CHU Besançon — Besançon
• CHU Bourdeaux — Bourdeaux
• CHU Lyon — Lyon
• CHU Montpellier — Montpellier
• Centre Hospitalier Universitaire Rangueil — Toulouse

Greece · 5 centers

• Hippokration Hospital Athens — Athens
• Mitera Hospital Athens — Athens
• Onassis Cardiac Surgery Center — Athens
• European Interbalkan Medical Center — Thessaloniki
• Hippokration Hospital of Thessaloniki — Thessaloniki

Italy · 2 centers

• Careggi University Hospital — Florence
• Centro Cardiologico Monzino — Milan

Portugal · 2 centers

• Hospital de Santa Cruz — Carnaxide
• Hospital de Santa Marta — Lisbon

Tunisia · 2 centers

• Rabta Hospital — Tunis
• The Military Hospital of Tunis — Tunis

Serbia · 1 center

• Dedinje Cardiovascular Institute — Dedinje

Identifiers

NCT: NCT04405583 · Occ2020_01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗